FDA Class I UDI Submission Deadline
FDA Class I
Class I and Unclassified medical devices that are required to be labeled with a UDI code, must submit product data to the FDA GUDID by December 8, 2022.
Note that the FDA has provided a Final Guidance outlining exceptions for “Consumer Health Products,” i.e., certain Class I devices that are 510(k) Exempt and only sold OTC directly to consumers. (Guidance finalized on July 22, 2022, previous enforcement date was September 24, 2022.)
If you market your Class I device according to one or more of the following conditions, the Class I GUDID Submission Exception does NOT apply and you must report product data to the FDA GUDID.
- You distribute your Class I device to professional healthcare facilities (hospitals, clinics, physician offices, etc.)
- Your Class I device is intended only for use by healthcare professionals
- Your Class I device is reused on different patients and reprocessed using high-level disinfection and/or sterilization
- Your Class I device requires 510(k)
If any of the above conditions apply, you have come to the right place…
Reed Tech can efficiently help you achieve compliance and relieve your team of this regulatory burden of reporting your Class I devices, Unclassified devices, and any outstanding Class III or II devices to the FDA GUDID. The Reed Tech SingleSource™ solution enables you to quickly and affordably comply with regulatory product data submission requirements. It provides a single, scalable, and flexible data management platform that allows you to collect, maintain, validate, and submit product UDI data to the FDA and other global health authorities as necessary.
If you have 25 or fewer Class I medical devices, Reed Tech has a targeted solution for you to report UDI product data to the FDA GUDID.
If you’ve already started the process, keep that momentum going. Contact Reed Tech for experienced help and check this off your list. Learn more about how we can help.
Need expert help with UDI submissions to FDA?
See the recent presentation and slides concerning ‘What to Know’ when it comes to Class I UDI compliance for 2022.
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